Piezosurgery

FDA 510(k) K052518 · Piezosurgery S.R.L.

Substantially Equivalent

510(k) numberK052518

Submission

Device name
Piezosurgery
Applicant
Piezosurgery S.R.L.
Rome, IT
Received
September 14, 2005
Decision date
November 16, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ELC – Scaler, Ultrasonic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4850
Specialty
Dental

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More from Guilin Refine Medical Instrument Co., Ltd.

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Questions and answers

When was Piezosurgery cleared by the FDA?

Piezosurgery (K052518) received a 510(k) decision of Substantially Equivalent on November 16, 2005, 63 days after the submission was received.

What is the product code of K052518?

The FDA product code is ELC – Scaler, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 872.4850.